The Assembly of the International Council for Harmonisation (ICH) met in person in Madrid, Spain, on 13 & 14 May 2025. The Assembly coincided with meetings of 11 Working Groups and was preceded by meetings of the ICH Management Committee (MC) and the MedDRA Steering Committee. The Assembly was chaired by Lenita Lindström (EC, Europe, ICH Assembly Chair) and Dr Gabriela Zenhäusern (Swissmedic, Switzerland, ICH Assembly Vice-Chair).
The ICH continues to expand, and was delighted to welcome DINAVISA, Paraguay; MOH, Kuwait; and SRS, El Salvador as new ICH Observers, bringing ICH to a total of 23 Members and 41 Observers.
Mr. Daisuke Koga, MHLW/PMDA, Japan, was appointed the new ICH MC Vice-Chair, being elected to serve until the end of the next ICH meeting in November 2025 following the mid-term departure of the previous Vice-Chair, Mr. Naoyuki Yasuda, MHLW/PDMA, Japan.
Progress on ICH Guideline development and important revisions
Final Guideline adopted at Step 4
The ICH E6(R3) Revised Guideline on “Good Clinical Practice” was adopted by the ICH Assembly (Step 4) in January 2025. The Guideline builds on key concepts outlined in ICH E8(R1) “General Considerations for Clinical Studies”. The Guideline is comprised of principles and annexes that provide specific details for different types of clinical trials.
Draft Guidelines endorsed at Step 2 a/b
- The ICH M4Q(R2) draft Guideline “The Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Use: Quality” was endorsed by the ICH Assembly (Step 2a/b) in May 2025. This multidisciplinary revision updates the structure and content of CTD Modules 2 and 3 to better support the registration and lifecycle management of all pharmaceutical products;
- The ICH E21 draft Guideline “Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials” was endorsed by the ICH Assembly (Step 2a/b) in May 2025. The objective of this guideline is to provide recommendations for the appropriate inclusion and/or retention of pregnant and/or breastfeeding individuals in clinical trials;
- The ICH Q1 draft Guideline on "Stability Testing of Drug Substances and Drug Products” was endorsed by the ICH Assembly (Step 2a/b) in April 2025 – for more information see the ICH website;
- The ICH M13B draft Guideline on "Bioequivalence for Immediate-Release Solid Oral Dosage Forms – Additional Strengths Biowaiver" was endorsed by the ICH Assembly (Step 2a/b) in March 2025 – for more information see the ICH Website;
- The ICH M11 “Clinical Electronic Structured Harmonised Protocol (CESHARP)” updated version of the Technical Specification document was endorsed by the ICH Assembly (Step 2a/b) in March 2025 – for more information see the ICH Website;
New areas of ICH harmonisation
The Assembly adopted four new topics for harmonisation at the Madrid meeting, the starting timeframe for which will be determined in a subsequent step:
- “Considerations for the Use of Real-World Evidence (RWE) to Inform Regulatory Decision Making with a focus on Effectiveness of Medicines” – a Guideline that proposes a systematic approach to using RWE in regulatory decision making;
- “Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs” – a Guideline to support determining the utility of comparative efficacy studies (CES) in biosimilar development programs;
- “Natural History Studies and Registry Data to Advance Rare Disease Drug Development” – this Guideline will provide harmonised principles for designing and conducting natural history studies and registries in rare diseases;
- “Comparability of Advanced Therapy Medicinal Products (ATMPs) Subject to Changes in Their Manufacturing Process (Annex to ICH Q5E)” – this annex to the Guideline ICH Q5E will address the unique development and regulatory challenges of ATMPs.
The next ICH Assembly meeting is scheduled to take place in Singapore on 18 and 19 November 2025.
Further information can be found in the ICH press release: ICH website